BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE2 4MMX23MM

    MDR report key: 17912765 · Received October 11, 2023

    Report

    Report Number
    3008114965-2023-00722
    Event Type
    Malfunction
    Date Received
    October 11, 2023
    Date of Event
    September 26, 2023
    Report Date
    November 14, 2023
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). COMPLAINT CONCLUSION: AS REPORTED BY THE FIELD, DURING A STENT ASSIST COIL EMBOLIZATION, AFTER A PROWLER SELECT PLUS 150/5CM (606S255X, 31032659 MICROCATHETER WAS PLACED IN TARGET SITE, AN ENTERPRISE2 4MMX23MM INTRACRANIAL STENT (ENCR402312, 7190236) WAS DELIVERED INTO THE MICROCATHETER (MC). THE STENT WAS IMPEDED IN MIDDLE SECTION OF THE MICROCATHETER AND COULD NOT ADVANCE ANY MORE. THE PHYSICIAN REMOVED THE MICROCATHETER AND STENT FROM THE PATIENT¿S BODY AND SWITCHED NEW DEVICES TO COMPLETE THE SURGERY. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THEY WERE NO ABLE TO MOVE THE DEVICE AT ALL DUE TO THE RESISTANCE. THEY WERE NO ABLE TO TORQUE THE DEVICE. THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. THE RESISTANCE WAS FELT AT THE BODY/SHAFT OF THE DEVICE. AN UNSPECIFIED GUIDEWIRE WAS USED SUCCESSFULLY WITH THE CONCOMITANT DEVICE PRIOR TO THE ENCOUNTERED RESISTANCE. THE MC DID NOT KINK OR BENT WHILE IN USE. THERE WERE NO PROCEDURAL DELAYS DUE TO THE EVENT. SHOW ACTIONS A NON-STERILE 4MM X 23MM ENTERPRISE2 WAS RECEIVED CONTAINED IN THE DECONTAMINATION POUCH. UPON RECEIVING THE DEVICE, A VISUAL INSPECTION WAS PERFORMED, AND IT WAS OBSERVED THAT THE STENT WAS RETURNED DETACHED FROM THE DELIVERY WIRE AND THIS WAS NO RETURNED FOR EVALUATION. THE DELIVERY WIRE AND THE INTRODUCER WERE FOUND WITHOUT DAMAGES (I.E., NO KINKS, BENTS, OR ELONGATIONS). THE DELIVERY WIRE WAS INSPECTED UNDER A MICROSCOPE, AND NO DAMAGES WERE FOUND ON IT. RESIDUES OF SALINE SOLUTION WERE NOTED INSIDE THE INTRODUCER COMPONENT. THE ISSUE DOCUMENTED THAT THE STENT BECAME IMPEDED IN THE MIDDLE SECTION OF THE MICROCATHETER CANNOT BE EVALUATED THROUGH FUNCTIONAL TEST SINCE THE STENT WAS FOUND TO BE NO LONGER ON THE DELIVERY WIRE. IN ADDITION, NONE OF THE RETURNED COMPONENTS PRESENTED DAMAGES TO SUGGEST THAT THEY WERE FORCIBLY ADVANCED BECAUSE OF THE RESISTANCE ENCOUNTERED DURING THE PROCEDURE. THE DETACHMENT OF THE STENT WAS NOT ORIGINALLY REPORTED, AND WITH THE INFORMATION AVAILABLE, IT IS NOT POSSIBLE TO DETERMINE THE TIME OF OCCURRENCE OF THIS CONDITION. WITH THE LIMITED EVIDENCE AVAILABLE, THE ROOT CAUSE CANNOT BE DETERMINED. IT IS POSSIBLE THAT CLINICAL AND PROCEDURAL FACTORS, INCLUDING DEVICE MANIPULATION, PATIENT'S VESSELS, AND OPERATOR'S TECHNIQUE, MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE. THERE IS NO INDICATION THAT THE ISSUE REPORTED IN THE COMPLAINT IS A RESULT OF A DEFECT INHERENTLY RELATED TO THE ENTERPRISE DEVICE. LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF THE LOT 7190236. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. AS PART OF THE CERENOVUS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. SINCE THERE IS NO EVIDENCE TO SUGGEST THAT THE ISSUE ENCOUNTERED DURING THE PROCEDURE IS RELATED TO THE DESIGN OR MANUFACTURE OF THE DEVICE, NO CAPA ACTIVITY IS REQUIRED. IT SHOULD BE NOTED THAT PRODUCT FAILURE COULD BE CAUSED BY MULTIPLE FACTORS. THE INSTRUCTIONS FOR USE (IFU) DO CONTAIN THE FOLLOWING RECOMMENDATION: DO NOT APPLY UNDUE FORCE IF RESISTANCE IS ENCOUNTERED AT ANY POINT DURING STENT MANIPULATION. WITHDRAW THE UNIT AND ADVANCE TO A NEW ONE. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED TO IDENTIFY STATISTICAL SIGNALS FOR CONSIDERATION OF FURTHER CORRECTION ACTION. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). SECTION B5: ADDITIONAL INFORMATION RECEIVED ON 18-OCT-2023 INDICATED THAT THEY WERE NOT ABLE TO MOVE THE DEVICE AT ALL DUE TO THE RESISTANCE. THEY WERE NTO ABLE TO TORQUE THE DEVICE. THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. THE RESISTANCE WAS FELT AT THE BODY/SHAFT OF THE DEVICE. AN UNSPECIFIED GUIDEWIRE WAS USED SUCCESSFULLY WITH THE CONCOMITANT DEVICE PRIOR TO THE ENCOUNTERED RESISTANCE. THE MC DID NOT KINK OR BENT WHILE IN USE. THERE WERE NO PROCEDURAL DELAYS DUE TO THE EVENT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. SECTION E1. INITIAL REPORTER PHONE: (B)(6). SECTION H3 - THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION AND TESTING. HOWEVER, IT HAS NOT BEEN RECEIVED TO DATE AS INDICATED AS ¿OTHER¿ IN THIS SECTION AS THE REASON FOR NON-EVALUATION. IF THE DEVICE RETURNS, A DEVICE INVESTIGATION WILL BE PERFORMED. MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS BLANK; THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. THE COMPANY IS SEEKING THIS INFORMATION THROUGH THE EVENT INVESTIGATION. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY CERENOVUS, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, CERENOVUS, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE COMPLAINT AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3008114965-2023-00723.

    Description of Event or Problem · 0

    AS REPORTED BY THE FIELD, DURING A STENT ASSIST COIL EMBOLIZATION, AFTER A PROWLER SELECT PLUS 150/5CM (606S255X, 31032659 MICROCATHETER WAS PLACED IN TARGET SITE, AN ENTERPRISE2 4MMX23MM INTRACRANIAL STENT ( ENCR402312, 7190236) WAS DELIVERED INTO THE MICROCATHETER (MC). THE STENT WAS IMPEDED IN MIDDLE SECTION OF THE MICROCATHETER AND COULD NOT ADVANCE ANY MORE. THE PHYSICIAN REMOVED THE MICROCATHETER AND STENT FROM THE PATIENT¿S BODY AND SWITCHED NEW DEVICES TO COMPLETE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2067178 ENTERPRISE2 4MMX23MM INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL 7190236

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown PROWLER SELECT PLUS 150/5CM.